Tenax details LEVEL-2 protocol changes and Type C meeting after LEVEL miss

Tenax Therapeutics reported financial results for the quarter ended September 30, 2026 and gave a corporate update on November 5, 2026. In August 2026, Tenax had announced that LEVEL, its first Phase 3 trial of oral levosimendan in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction, missed its primary and key secondary endpoints, though it showed some biological effects on cardiac and pulmonary measures across the full study population.¹

In exploratory analyses of the overall trial group, the company reported that patients on TNX-103 saw NT-proBNP drop 49% more than placebo (nominal p<0.0001), along with a 3.5 mmHg greater reduction in right ventricular systolic pressure (nominal p=0.0045).¹ The company said TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced between treatment arms.¹

On October 8, 2026, Tenax disclosed it had finished a multivariable analysis of the LEVEL data identifying baseline traits linked to stronger treatment response, laid out a predictive enrichment approach for LEVEL-2, and paused enrollment in that trial while sites implement a protocol amendment.¹ Under the revised design, LEVEL-2 will enroll patients with a baseline six-minute walk distance of 100 to 300 meters, or 301 to 400 meters paired with a right atrial volume index of at least 25 mL/m².¹ In LEVEL patients who met those criteria, TNX-103 showed a 34-meter improvement in six-minute walk distance versus placebo at Week 12 (95% CI 15, 53; nominal p=0.001).¹

Tenax said it shared the LEVEL topline data with the FDA in mid-August and has since been granted a Type C meeting to discuss levosimendan's overall development path in PH-HFpEF.¹ The company said it expects to publish the LEVEL-2 protocol design paper and provide further updates on levosimendan's development in the first quarter of 2027.¹

On the balance sheet, Tenax reported cash and cash equivalents of $113.7 million as of September 30, 2026.¹ The company said it now expects that cash to support operations into fiscal 2028, but noted its operating plan could change depending on the outcome of the FDA Type C meeting.¹